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Oral TP-3654 for Myelofibrosis

Phase 1 & 2
Recruiting
Research Sponsored by Sumitomo Pharma America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Agree to provide bone marrow biopsies during the study: at baseline or within 12 weeks prior to enrollment, and every 6 months during treatment
- Splenomegaly during the screening period as demonstrated by splenic length ≥ 5 cm below the costal margin by palpation or spleen volume of ≥ 450 cm3 by Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is to test a new drug for people with a certain type of cancer. The study will see if the drug is safe and if it works.

Who is the study for?
This trial is for adults with primary or secondary myelofibrosis, a type of bone marrow cancer. They must have tried and failed JAK inhibitor treatment or be ineligible for it. Participants need to have certain blood counts, organ function within specific limits, and a life expectancy of at least 3 months. They can't join if they've had recent surgeries or other treatments that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing TP-3654, an oral medication for myelofibrosis patients who are at intermediate or high risk. It's in early stages (Phase 1/2) to see how safe it is and how the body responds to different doses. Patients will also undergo regular bone marrow biopsies to monitor effects.See study design
What are the potential side effects?
Since this is an early-phase trial assessing safety and tolerability, exact side effects aren't listed but may include typical reactions such as nausea, fatigue, liver issues based on similar drugs' profiles; close monitoring will identify any potential adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to give bone marrow samples at the start and every 6 months during the study.
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My spleen is enlarged, confirmed by a doctor's exam or imaging tests.
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I have been diagnosed with a type of myelofibrosis and it's considered intermediate or high-risk.
Select...
I have tried a JAK inhibitor for my condition without success or cannot use Ruxolitinib or Fedratinib.
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My kidney function is within the required range.
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I can take care of myself but might not be able to do heavy physical work.
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I have at least 2 symptoms of my condition that can be measured.
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My liver functions and blood clotting levels are within the required range.
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I have tried a JAK inhibitor for my condition and it didn't work or I can't take Ruxolitinib or Fedratinib.
Select...
My recent tests show significant scarring in my bone marrow.
Select...
I have been diagnosed with a type of myelofibrosis and it's considered intermediate or high-risk.
Select...
My white blood cell count is healthy without needing medication to help.
Select...
I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the incidence of dose-limiting toxicities (DLTs) at escalated doses of TP-3654
Determine the incidence of treatment emergent adverse events
Secondary outcome measures
Assess patients for any evidence of Preliminary activity by proportion of patients with responses in complete remission, partial remission, clinical improvement, progressive disease and stable disease
Assess the reduction in bone marrow fibrosis in repeat biopsies
Determine Overall Survival
+9 more
Other outcome measures
Study potential pharmacodynamic (PD) markers of TP-3654

Trial Design

1Treatment groups
Experimental Treatment
Group I: TP-3654Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TP-3654
2019
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,712 Total Patients Enrolled
Sumitomo Dainippon Pharma Oncology, IncLead Sponsor
41 Previous Clinical Trials
6,579 Total Patients Enrolled
Sumitomo Pharma Oncology, Inc.Lead Sponsor
44 Previous Clinical Trials
6,900 Total Patients Enrolled

Media Library

TP-3654 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04176198 — Phase 1 & 2
Myelofibrosis Research Study Groups: TP-3654
Myelofibrosis Clinical Trial 2023: TP-3654 Highlights & Side Effects. Trial Name: NCT04176198 — Phase 1 & 2
TP-3654 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04176198 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate figure of participants in this experiment?

"This study necessitates the enrollment of 60 individuals who meet its inclusion requirements. Individuals can become a part of this trial at sites such as University of Virginia Cancer Center in Charlottesville, Virginia and The University of Arizona Cancer Center in Tucson, Arizona."

Answered by AI

What is the targeted outcome of this experiment?

"The chief aim of this 28-day medical trial is to gauge the occurrence of treatment-related side effects. Secondary objectives include ascertaining the peak plasma concentration (Cmax) level, determining any changes in QT interval and morphology using Holter ECG monitoring, and noting shifts in patient global impression of change (PGIC) scores at week 24."

Answered by AI

Is this project actively gathering participants?

"According to clinicaltrials.gov, recruitment of participants is still ongoing for this medical trial which was published on December 16th 2019 and updated as recently as May 26th 2022."

Answered by AI

How many venues are participating in this trial?

"Six centres are executing this clinical trial, including the University of Virginia Cancer Centre in Charlottesville, The University of Arizona Cancer Center in Tucson and Duke Cancer Institute in Durham. An additional three medical institutes across the United States are also participating."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
How old are they?
65+
What site did they apply to?
The University of Arizona Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
~11 spots leftby Dec 2024